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Related Experiment Videos

The StarClose Vascular Closure System: interventional results from the CLIP study.

J B Hermiller1, C Simonton, T Hinohara

  • 1St. Vincent's Hospital, Indianapolis, Indiana, USA.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
|October 14, 2006
PubMed
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The StarClose Vascular Closure System is as safe as manual compression for femoral artery closure after percutaneous procedures. It significantly speeds up hemostasis, ambulation, and discharge.

Area of Science:

  • Cardiovascular Interventions
  • Medical Device Technology
  • Clinical Trial Research

Background:

  • The StarClose Vascular Closure System utilizes a nitinol clip for extravascular closure of arteriotomies.
  • It is designed for femoral access site closure following catheterization procedures.

Purpose of the Study:

  • To evaluate the safety and efficacy of the StarClose device in patients undergoing diagnostic and interventional catheterization.
  • To compare StarClose to standard manual compression for arteriotomy closure.

Main Methods:

  • A randomized trial involving 596 subjects across 17 U.S. sites.
  • 483 subjects were randomized 2:1 to StarClose or manual compression.
  • Primary endpoints included major vascular complications (safety) and time to hemostasis (efficacy).

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Main Results:

  • Major vascular complications were similar between StarClose (1.1%) and manual compression (1.1%) groups.
  • StarClose showed a trend towards fewer minor complications (4.3% vs. 9.9%) and no pseudoaneurysms or fistulas.
  • Procedural success rates were high for both groups (100% diagnostic, 98.9% interventional).

Conclusions:

  • The StarClose Vascular Closure System is noninferior to manual compression for major vascular events in percutaneous interventional procedures.
  • StarClose significantly reduced time to hemostasis, ambulation, and dischargeability compared to manual compression.